510(k) · Cleared
ClearedPowder-Free Poly-Vinyl Exam Gloves, Color: White
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copioumed Intl., Inc. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 2, 2002 as substantially equivalent to K992979 (Shanghai Poseidon Plastic Products Co., Ltd., 2000) and 1 other predicate after an 18-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jul 2, 2002
- Review
- 18 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992979 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK992979 Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves…Shanghai Poseidon Plastic Products Co., Ltd. · 2000
- This deviceK021961 Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteCopioumed Intl., Inc. · 2002
- Descendant · cites it directly · 0 of its ownK030927 Powdered Vinyl Exam Gloves, WhiteCopioumed Intl., Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K030927Powdered Vinyl Exam Gloves, WhiteCopioumed Intl., Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992979 | Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves, Yellow | Shanghai Poseidon Plastic Products Co., Ltd. | 2000 | — |
| 0 (this device) | K021961 | Powder-Free Poly-Vinyl Exam Gloves, Color: White | Copioumed Intl., Inc. | 2002 | — |
| +1 | K030927 | Powdered Vinyl Exam Gloves, White | Copioumed Intl., Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992979 | Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves, YellowSummary page 1…is substantially Equivalent to the devices manufactured by Shanghai Poseidon Plastic Products Company Limited, (K992979) and Glormed International (K002340) 5 1Ok) Summary page 2. Test Results (Means and/or Successfid Results:… | 2000 |
| * | K002340 | Vinyl Examination Glove, Powder-Free, YellowSummary page 1…he devices manufactured by Shanghai Poseidon Plastic Products Company Limited, (K992979) and Glormed International (K002340) 5 1Ok) Summary page 2. Test Results (Means and/or Successfid Results: This device has met or ex… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030927 | Powdered Vinyl Exam Gloves, White | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021961 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021961: Powder-Free Poly-Vinyl Exam Gloves, Color: White.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021961
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026